EP1575833B1 - Method for the production and/or handling of a highly pure object - Google Patents

Abstract

A method of manufacturing or handling a substantially pure object includes shielding the substantially pure object from the environment by substantially enveloping the object in a fluid. A system for manufacturing a substantially pure object includes a mold for forming the object, and a machine adapted to remove the object from the mold. The machine includes a handling device for gripping the object and removing it from the mold. The handling device includes at least one nozzle through which fluid is delivered to substantially envelope the object during, for example, removal of the object from the mold. The object may be a medical object, such as a syringe, or a component or part thereof, such as a syringe barrel or plunger. In a preferred aspect, a molding process is conducted in a room exhibiting less than Class 100 conditions and/or in such a way that the object does not need to be subsequently cleaned or rinsed, as by air or water washing.

Description

The invention relates to a method for producing and / or handling a high-purity article, in particular a medical container, for example a prefillable container for receiving medicaments. Furthermore, the invention relates to a corresponding device for handling such a high-purity object.

Medical containers are known which are used for storing substances for medicine and pharmacy. Such containers are especially prefillable containers such as e.g. prefillable bottles or prefillable syringes made of glass or even plastic, which is delivered pre-filled with a drug.

Such containers for storing substances for medicine and pharmacy must meet two main aspects, namely to protect the substance to be stored from changes and, secondly, to protect the contents of the container from contamination. The regulatory minimum requirements are described for example in the pharmacopoeias and therefore mandatory. Specifically, product requirements can go much further.

Possible impurities such as particles or germs can not only be subsequently introduced from the environment into the container, Rather, they can also originate from the container itself, ie, for example, in or through the production process of the container to be in or on this. Therefore, the relevant regulations set maximum levels for permissible particle and endotoxin loads.

In particular, contamination of plastic articles may occur due to having an electrostatic charge after the manufacturing and demolding process, which attracts particles from the ambient air and also prevents rinsing of adhering particles. Therefore, in conventional manufacturing processes used to unload the plastic parts after demolding. However, the discharge is often incomplete and recharge effects occur in which charges from the interior of the plastic parts reach the surface over a longer period of time.

Usually, particle and endotoxin loads are prevented by washing the containers before filling, as described, for example, in US Pat US 4,718,463 is described. In addition, these containers are usually deppyrogenated by the application of high temperatures up to 300 ° Celsius. However, this application of high temperatures can only be used with containers made of glass, since containers made of plastic would usually be destroyed at these temperatures.

Therefore, other methods are used to make and clean plastic containers. So describes US 5,620,425 the preparation of a prefillable syringe barrel in a Class 100 clean room, which is intended to avoid contamination during manufacture of the syringe barrel. The complete production of a syringe body or a syringe in a clean room, however, is very expensive. Thus, a class 100 clean room atmosphere can only be produced via a laminar flow, which, however, is in one Injection molding machine by the opening and closing movement of the machine is difficult or impossible to maintain and is easily disturbed by working in the clean room people. Therefore, the in US 5,620,425 described conditions in the production of a plastic syringe in the injection or not very difficult to maintain in order to achieve the required sterility. In addition, the cleanroom conditions and their suitability for the respective product must first be elaborately validated and then intensively monitored during operation. Overall, therefore, the operation of such clean rooms is a considerable effort, which leads to a significant increase in the cost of manufactured products.

US 6,164,044 . US 6,189,292 . US 6,263,641 and US 6,250,052 describe therefore a further manufacturing method for producing prefillable containers made of glass or plastic. According to the methods described in these patents, after manufacture, the containers or syringe barrels are placed in a sealed system by casting or forming glass or by injection molding plastic for further processing. This system consists of individual containers or cabinets, in which a clean room atmosphere prevails. When the containers made outside of this clean room atmosphere are brought into the closed system, they are first cleaned by a stream of purified air, so that any adhering particles or germs are rinsed from the containers. Subsequently, the containers thus cleaned are further processed in the system in which class 100 clean room conditions prevail.

This plant also has the disadvantage that clean room conditions of class 100 must be created for the entire handling and filling in the closed cabinets or containers. Furthermore, there is a risk that, despite the initial cleaning of the Adhere containers manufactured outside the clean room system to these germs or particles.

US 5,687,542 discloses an apparatus according to the preamble of claim 25 for manufacturing syringes, for example. In this device, an injection molding machine is provided and a directly adjacent processing station, within which there are better clean room conditions than in the environment. After injection molding the article, the tool is opened and the article moved directly into the adjacent processing station. In this case, high-purity air is directed from the processing station in the direction of the tool in order to prevent the ingress of contaminants into the processing station.

It is an object of the invention to provide a new method and an apparatus for producing and / or handling a hot-formed, initially high-purity object such as a medical container, which allow a cost-effective and simple production while ensuring greater purity. In particular, a more efficient method for producing medical containers is to be created, which meets and exceeds the requirements of the pharmacopoeias with regard to cleanliness, in particular with respect to particles and / or endotoxins and can dispense with the use of very clean clean rooms, in particular class 100.

This object is achieved by a method having the features specified in claim 1 and by a device having the features specified in claim 25. Preferred embodiments will be apparent from the dependent claims.

The method according to the invention relates to the production and / or handling of a high-purity article. Such an article may, for example, be a medical or medical article which must be highly pure, that is essentially free of germs and particles. According to the method, the high-purity object is shielded from the environment during a handling operation by a fluid which flows around the object. In this case, at least the parts of the object are constantly flowed around by the fluid during the entire handling process, which must have the required purity. So these parts are constantly kept in a defined protective atmosphere. This ensures that an initially high-purity object during handling and further processing is not contaminated by contact with the ambient air. Thus, a special clean room environment and / or subsequent cleaning steps can be dispensed with, whereby the manufacturing process is simplified. Furthermore, greater purity can be ensured because contaminants of the article can be prevented from the beginning rather than being removed in later purification steps, with a complete cleaning Removal of impurities during cleaning is usually not possible. Furthermore, the method has the advantage over known methods, in which the article is rinsed with a fluid shortly before cleaning, that lower flow velocities of the fluid and smaller amounts of fluid for shielding the article are sufficient. Furthermore, the omission of a cleaning step causes a shortening of the entire manufacturing process, which in addition to a higher efficiency of the process causes a reduction of the risk of contamination of the article. By directly shielding the article by the surrounding fluid during the manufacturing process and during handling, transfer steps between different environments can be avoided. The article always remains in the environment created by the circulating fluid.

The article is an article heat-formed in a tool, the article being shielded from the environment by the fluid flowing around it during the entire removal operation from the tool. The article is for example an article made of metal or plastic, which has been produced in the casting process, eg injection or die casting in the tool. The invention exploits the effect that a hot-formed, for example, made of molten plastic article after solidification has a perfect cleanliness. This is especially true in terms of particles and due to the melting temperatures up to more than 300 ° C also in terms of endotoxins. By flowing around the freshly formed object during removal from the tool prevents the perfectly clean due to the manufacturing process object is subsequently contaminated. The article does not come into contact with the ambient air at all due to the flow around it with a fluid, so that contamination of the article is prevented from the beginning. This has the advantage that no particularly clean environmental conditions must be created, so can be dispensed with in the manufacture of medical items or containers, for example, expensive and expensive class 100 clean rooms. Since according to the invention contamination of the article is prevented from the beginning, it is also not necessary, as in the prior art, to clean the article before further processing by means of an air shower or the like. According to the invention, the pure, protected by the enveloping fluid from contamination object can be given directly without intermediate step in a further processing. Thus, a total of a very cost effective and effective manufacturing process can be created.

The method is particularly preferably suitable for producing an article which is part of a medical container or a medical container. Such a container may be, for example, a prefillable vial or syringe made of a suitable plastic, in particular a barrier plastic, which are molded in the tool. The molding of the container part or container is preferably carried out by injection molding or injection blow molding. According to the method according to the invention, all parts or components of a medical container, in particular those parts which come into contact with a drug, can be manufactured and handled without becoming contaminated following the molding process. It is by the shield by means of Fluids achieved that it is not necessary to re-clean or rinse the container before filling. The originally given purity or sterility on removal from the mold is maintained until filled, without the handling process having to take place in a special class 100 cleanroom.

Preferably, the fluid that flows around the article is a gas, in particular air or filtered air. By filtering the required germ and particle freedom of the gas or the air can be ensured. Preferably, 0.2 micron filters or filters with even smaller pore diameters are used to ensure the required cleanliness of the air. The air or filtered air surrounds the object as completely as possible, so that an air envelope is created, which protects the clean due to the preceding manufacturing process object from the potentially contaminated ambient air.

More preferably, the fluid that flows around the article is conditioned air. For example, the air may be moistened to allow for removal of the article, e.g. a container part from the tool to prevent static charges or compensate. Static charges of the article are avoided by the direct use of the conditioned air during removal of the object from the tool from the outset, so that adhesion of particles or germs due to static electricity can be prevented. Preferably, upon removal of a container part or container from the mold, the cavity formed in the container part during demoulding of the core is ventilated directly with the gas flowing around, in particular filtered and / or conditioned air.

Still more preferably, the fluid that flows around the article is ionized air. It can be filtered, conditioned and ionized air act. In this way, the object to be handled comes into contact only with the air conditioned in this way, and an electrostatic charge which possibly arises during the removal process by friction can be compensated for in statu nascendi, ie directly at the time of formation. Also, since no more charges, they also no longer get into the interior of a plastic matrix, which counteracts together with the below-described Nachladseffekten, as they occur in known methods. Further, the flow around the article causes the article to be in contact with the fluid or gas for a very long time. This has over known air showers or curtains, through which an object or container part is performed for cleaning or gravity falls through, the advantage that can be used with relatively low discharge currents and recharging effects, as they occur in the prior art, be compensated. Preferably, furthermore, the charge of the article may be measured and the flow of ionized air controlled such that the charge occurring in the article is accurately compensated for without re-unwanted charging. In addition, the grippers holding the article may be grounded to dissipate charges.

The fluid that flows around the article may also preferably contain at least as a component a germicidal fluid or gas. Thus, by using a germicidal fluid or admixture of germicidal substances in the fluid or gas additionally carried out a killing of germs, which are located in the ambient air. As a germicidal gas, for example, a H ₂ O ₂ -containing gas or ozone or the like. be used. As an alternative to germicidal gas, as already described, purified air, CO ₂ , noble gases or other gases can be used for flowing around or enveloping the object, in particular during removal from the mold. It can all suitable gases are used, which create a high-purity atmosphere in the immediate vicinity of the object to prevent contamination by the ambient air.

The flow around the article expediently begins when the object is still in the tool. Particularly preferably, the flow around or wrapping of the article begins immediately after opening the tool, so that the object thus produced does not come into contact with the ambient air at all. In this way, contamination of the sterile or clean manufactured object when opening the tool and during the removal and further processing can be reliably prevented.

Preferably, the removal of the object from the tool takes place in a defined manner by machine. By machine removal of the object can be removed in a predefined manner and with a predetermined speed from the tool. As a result, it can be achieved that a speed is always maintained in which it is ensured that the casing is not blown or damaged by the fluid or gas flowing around the object. Thus, it is also ensured during the movement of the object during the removal that it is shielded by the fluid from the ambient air. Furthermore, by the defined movement, the static charge when removing the object from the tool can be minimized. Also, the movement of the object to the tool in the machine removal can be controlled so that no particles as possible during removal of the object are formed, for example, due to friction between the tool and the object. The defined machine removal from the tool can be done for example by a robot arm or other suitable handling device, which can be operated at predetermined speeds and accelerations.

The object is particularly preferably removed from the tool by a robot and at the same time separated or ejected from the tool by an ejector arranged in the tool. This allows the removal of a plastic object in still relatively soft state. By the ejector and the robot gripping the object, the required removal or separation force to remove the object from the tool, applied to the object at several points. The material of the article must therefore transmit only lower forces when removing. As a result, selectively acting high forces, which could lead to deformation of the still soft object avoided.

Preferably, the removal of the article from the tool takes place with a low initial speed. This means that the object is first released from the tool at the lowest possible speed. Subsequently, the movement speed can be increased gradually or progressively to allow a quick handling. Due to the low initial speed, a clean separation of the object from the tool surface can be achieved without the demolding caused particles adhere to the surface of the article. Possible contamination of the object during the removal process from the tool are thus further minimized.

The removal of the article from the tool is preferably carried out before the complete cooling of the article. The removal of the article takes place at the highest possible removal temperature, which has a relatively soft plastic result. Here, too, the defined mechanical removal of advantage, since only such a deformation-free removal with still soft Plastic allows, in contrast to an exclusively tool-based demolding of the plastic article. The still soft plastic allows a clean detachment from the tool surface, without unwanted particles arise because the surface of the plastic at a microscopic level still has a certain plasticity. Furthermore, static charges due to friction can be minimized. The fluid that flows around the object when it is removed then ensures targeted cooling.

The removal of the object from the tool is carried out according to a preferred embodiment by a robot and on the robot at least one nozzle is arranged, through which the object is flowed around with the fluid. In this case, the nozzle or the nozzles are arranged as close as possible to a gripping device of the robot arm, which grip the object. This arrangement ensures that during the entire movement process of the object by the robot, the fluid flows around or envelops the object, so that the object is shielded from the ambient air. In this case, the object flows around as closely as possible in order to minimize the expansion of the atmosphere generated by the fluid or gas and thus the required amount of fluid.

In addition, nozzles may be arranged in at least part of the tool for flowing around the object with the fluid. Through these nozzles can be ensured that the object is already flowed around in the tool directly when opening the tool, so that it does not come into contact with the ambient air during the entire removal process from the tool. In this case, the nozzles for the fluid can be mounted in the movable and / or fixed part of the tool. The exact arrangement depends on the geometry of the tool and the component to be produced. The Nozzles are arranged so that when removing the component or container part is constantly flowed around by fluid or gas, in particular high purity air to prevent contamination with contaminants from the environment.

The tool preferably has a surface which is treated to have a minimum adhesion. This also contributes to the fact that during demolding no unwanted particles arise, which may possibly adhere to the surface of the article. Thus, a sufficiently clean object is created from the outset, which no longer requires any subsequent cleaning, since it is shielded according to the invention during the entire process by a circulating fluid from the ambient air. The surface of the tool is preferably formed with a not too low and not too large roughness in order to achieve the least possible adhesion between the object and the tool. In addition, the surface of the tool may be coated with suitable materials such as Teflon or titanium nitride. All other suitable coatings or methods for treating the tool surface may also be used to realize minimal adhesion between the article being produced and the tool.

In addition to the fluid flowing around the object can be surrounded by a protective bell directly on removal from the tool in addition to the flow around the fluid. Such a protective bell is a hollow body which is open at least on one side, so that the object can enter the bell through the opening. The bell may for example consist of plastic or metal and is preferably attached to a robot arm, which removes the item from the tool and further handles. In this case, the fluid flowing around the object, in particular a gas, is preferred directed so that it fills the bell completely, so that no possibly contaminated ambient air enters the bell. The bell has the advantage that, even with a rapid movement of the container part by the robot arm, a fading of the fluid or gas layers surrounding the article is reliably prevented. Thus, a sufficient shielding from the ambient air can be ensured at any time during movement of the object.

The removal of the object from the tool is preferably followed by automatic or semi-automatic further processing. This can include one or more further processing steps, such as, for example, in the case of a medical container or container part, siliconization, inspection, assembly, labeling, filling, packaging, etc. This further processing can take place in a closed system in which sufficient clean room conditions prevail, such as for example US 6,189,292 . US 6,263,641 . US 6,250,052 and US 6,164,044 is known. Because he originally given clean parts according to the invention in the further processing, a greater freedom is achieved in the subsequent process, since the permissible tolerances for the contamination are less exhausted.

The shielding of the object removed from the tool by the fluid flowing around is also maintained in at least one subsequent handling and / or processing steps. Thus, even in these subsequent handling and / or processing steps on a clean room environment, in particular a class 100 cleanroom environment be dispensed with, since the object, preferably a container part, constantly shielded by the enclosure or the flow around the fluid from the ambient air. In this case, the surrounding fluid forms a steadily maintaining shell around the object, which prevents contamination. In order to be able to maintain this fluid sheath, in particular from high-purity air, corresponding air nozzles are carried along with the product or the container part. Preferably, the required nozzles are attached directly to a robot arm which moves the article. By keeping the article in the protective fluid envelope throughout the process, transfers between different environments through appropriate locks are eliminated, making the process easier and safer.

The flow around the object removed from the tool with the fluid can be used for rapid cooling of the container part. For example, in semi-crystalline plastics or to prevent crystallization, a targeted rapid cooling of the article may be desired. By appropriate temperature control of the fluid, with which the article flows around, a correspondingly fast defined cooling can be achieved.

Alternatively, the flow around the object removed from the tool with the fluid for slow cooling can be used. This may be desirable, for example, to eliminate or prevent cooling stresses, for example in amorphous plastics. The fluid used can be appropriately tempered to achieve a targeted slow cooling of the article. By appropriate temperature control of the volume flow of the fluid thus the cooling rate of the removed from the tool article can be selectively adjusted over a wide range depending on the type of plastic or material used.

The article is preferably assembled with other components. In this case, both the object and optionally the other components in the manner described by a fluid flow be protected from contamination from the ambient air.

In particular, the article may be a container, e.g. a medical container, which is assembled and / or filled with other components and sealed. In this case, several or all of the container parts to be assembled can be removed and handled from a tool in the manner described above. Thus, for example, the syringe body and cap of a syringe to be prefilled can be handled accordingly, so that all parts of the container or a prefillable syringe that come into contact with a drug are protected from contaminants from the environment during the entire production or handling process.

In addition, at least individual process steps may take place in a controlled environment of class 1000 or lower purity. A clean room environment of class 100, as required in the prior art, according to the inventive method is not necessary because the object to be handled or the container part to be handled is constantly protected by the circulating fluid from contamination. Of course, cleaner clean room classes do not degrade the result and can be used in those process steps where they are used e.g. required by official regulations.

According to a further preferred embodiment of the invention, a siliconization of the article takes place directly after the removal of the article from the tool. Such siliconization is required, for example, in the manufacture of prefillable medical containers. The siliconization directly after removal from the tool, if the object preferably not yet complete cooled, has the advantage that the surface of the object is already activated. Thus, plastic articles require no additional activation prior to siliconization, which further simplifies and speeds up the manufacturing process. After the siliconization, a visual inspection with the eye or automatically with a camera can then additionally be carried out, wherein at the same time the perfect condition of the article as well as the quality of the siliconization can be checked.

Furthermore, the fluid flowing around the article can additionally be used to influence the surface properties of the article. Thus, the fluid, and in particular the gas, may be chosen to undergo predetermined reactions with the surface layer of the article to achieve certain surface properties. Alternatively, appropriate adjuvants may be added to the fluid. In addition, by the fluid flow auxiliaries and reactants can be removed again.

Particularly preferably, the fluid flowing around the article is used for hardening and / or drying a surface coating. This surface coating may be, for example, silicone, which has been applied in a siliconization step. The gas flowing around, which protects the article from environmental influences, can accelerate the drying or hardening of the silicone.

The invention further relates to a device for handling a high-purity article, in particular a medical article such as a medical container or container part. For handling purposes, the handling device has at least one nozzle for the outflow of a fluid. In this case, the nozzle for the outflow of the fluid is arranged such that a in the handling device held by the fluid is flowed around. That is, at least one nozzle is arranged so that those parts of the article which are to be shielded from the ambient air are completely and continuously overflowed by the fluid, so that the fluid can form a protective layer around the article. The exact arrangement and number of nozzles used depends on the shape of the object to be protected.

Preferably, the handling device is a robot arm with a gripping device for grasping the object. In this case, the at least one nozzle is arranged in the vicinity of the gripping device. Thus, the object can be flowed around as directly as possible, so that the jacket formed by the fluid flow rests as closely as possible on the object. In this way, the amount of fluid required is reduced and a defined atmosphere surrounding the article is created, for example, from a high purity gas.

Furthermore, a protective shield which at least partially covers the outflowing fluid is preferably arranged on the handling device. Such a protective shield serves to prevent a movement or displacement of the fluid during movement of the handling device. Therefore, the shield is preferably arranged at least in the direction of movement in front of the fluid jacket and the object therein. More preferably, the protective shield is designed as a bell, which encloses the object and the fluid flow surrounding the object, so that the fluid jacket protecting the object can be maintained even with rapid movement of the handling device.

Fig. 1

eine perspektivische Gesamtansicht eines ersten Verfahrensschrittes,

Fig. 2

eine perspektivische Gesamtansicht eines zweiten Verfahrensschrittes,

Fig. 3

eine perspektivische Gesamtansicht eines dritten Verfahrensschrittes,

Fig. 4

eine Draufsicht auf eine Anordnung zum Umströmen eines zu schützenden Gegenstandes,

Fig. 5

eine perspektivische Ansicht der Anordnung gemäß Fig. 4,

Fig. 6

eine Draufsicht auf eine weitere Anordnung zum Umströmen eines zu schützenden Gegenstandes,

Fig. 7

eine perspektivische Ansicht der Anordnung gemäß Fig. 6,

Fig. 8

eine Schnittansicht und Draufsicht einer weiteren Anordnung zum Umströmen eines zu schützenden Gegenstandes,

Fig. 9

eine teilweise geschnittene perspektivische Ansicht der Anordnung gemäß Fig. 8,

Fig. 10 + 11

schematisch den Wechsel zweier Anordnungen zum Umströmen eines zu schützenden Gegenstandes,

Fig. 12

eine Draufsicht auf eine weitere Anordnung zum Umströmen eines zu schützenden Gegenstandes,

Fig. 13

eine perspektivische Ansicht der Anordnung gemäß Fig. 12,

Fig. 14

eine perspektivische Gesamtansicht einer Anlage zum Erzeugen und zur Weiterverarbeitung eines hochreinen Gegenanstandes,

Fig. 15

eine perspektivische Gesamtansicht einer weiteren Anlagen zur Erzeugung und Weiterverarbeitung eines hochreinen Gegenstandes und

Fig. 16 und Fig. 17

Flussdiagramme, in denen der Ablauf der Herstellung einer Spritze bzw. eines medizinischen Behälters nach den Verfahren gemäß Fig. 1 bis 15 gezeigt ist.

The invention is described below using the example of the production of a medical container with reference to the attached figures. In these shows:

Fig. 1

an overall perspective view of a first method step,

Fig. 2

an overall perspective view of a second method step,

Fig. 3

an overall perspective view of a third method step,

Fig. 4

a plan view of an arrangement for flowing around an object to be protected,

Fig. 5

a perspective view of the arrangement according to Fig. 4 .

Fig. 6

a plan view of another arrangement for flowing around an object to be protected,

Fig. 7

a perspective view of the arrangement according to Fig. 6 .

Fig. 8

a sectional view and a plan view of another arrangement for flowing around an object to be protected,

Fig. 9

a partially cutaway perspective view of the arrangement according to Fig. 8 .

Fig. 10 + 11

schematically the change of two arrangements for flowing around an object to be protected,

Fig. 12

a plan view of another arrangement for flowing around an object to be protected,

Fig. 13

a perspective view of the arrangement according to Fig. 12 .

Fig. 14

an overall perspective view of a plant for the production and further processing of a high-purity counterstay,

Fig. 15

an overall perspective view of another equipment for the production and processing of a high-purity object and

FIGS. 16 and 17

Flowchart in which the process of manufacturing a syringe or a medical container according to the method according to Fig. 1 to 15 is shown.

Based on FIGS. 1 to 3 schematically a preferred embodiment of the removal operation of a container part of a tool according to the present invention will be described. Fig. 1 shows a first process step in which the two mold halves 2 and 4 are opened. The container part made in the tool 2, 4 in the form of a plastic syringe 6 is still on a core on the tool 2. Annularly surrounding the core to the tool 2 nozzles 8 are arranged through which gas, preferably ionized and conditioned high-purity air Direction of in Fig. 1 arrows shown flows out. The outflow of air preferably begins with opening of the tool halves 2 and 4. The flow direction is such that the air flows as linearly as possible along the outside of the syringe 6 in the longitudinal direction. As a result, the container part, ie the syringe 6 surrounded by a protective jacket of high purity air, which flows out of the nozzles 8, and thus protected from contamination from the ambient air. Furthermore, this flushing operation with ionized air causes any static charges generated in the syringe 6 to be released when opening the tool halves 2 and 4. In this way it can be prevented that particles accumulate due to these static charges on the syringe surfaces.

Furthermore, in Fig. 1 a robot arm 10 is shown, on which a gripping device 12 for removing the syringe 6 from the tool half 2 is mounted. The gripping device 12 initially consists of a cylindrical bell 14, which has an opening 16 at its front through which the syringe 6 can be accommodated. In the region of the front, the opening 16 facing the end of the bell 14, two opposing grippers 18, 20 are arranged for holding the syringe 6. The grippers 18 and 20 can be linearly moved in the direction of the arrows A via actuators 22, 24 in order to grip the syringe 6. The actuators 22 and 24 may be hydraulically, pneumatically or electrically driven, for example. At its rear end facing away from the opening 16, the bell 14 has a gas inlet opening or nozzle 26 which communicates via a line 28 with a gas source, for example an air treatment device. Preferably, high purity, ionized and conditioned air is introduced through the conduit 28 through the gas inlet orifice 26 in the direction of the arrows in FIG Fig. 1 led into the interior of the bell 14. In this case, the air flows parallel to the longitudinal direction of the bell 14 to the opening 16 and exits through this into the open.

To remove the syringe 6 from the tool 2, the robot arm 10 is first moved in the direction of arrow B until the opening 16 of the bell 14 is arranged opposite to the syringe 6. Subsequently, the robot arm 10 is moved in the direction of the arrow C, so that the Bell 14 and the grippers 16 and 18 are slipped over the syringe 6, as in Fig. 2 is shown. The bell is in the direction of arrow C in Fig. 1 has been moved so that it completely surrounds the syringe 6 on the tool 2. The syringe 6 passes between the grippers 18 and 20. The grippers 18 and 20 are by the actuators 22, 24 in the direction of arrows A in Fig. 2 moved so that the syringe 6 is clamped between the grippers 18 and 20. At the same time, high purity, ionized and conditioned air continuously flows through the gas inlet opening 26 into the bell 14 and flows inside the bell on the outside of the syringe 6 and then exits through the opening 16 on the bell 14 to the outside. When the bell 14, the syringe 6 in the in Fig. 2 shown completely surrounds the gas flow through the nozzles 8 in the tool 2 can be switched off, since the syringe 6 is completely enclosed in this state by the gas or air flow in the bell 14. The air flow in the bell 14, causes the syringe 6 is completely shielded from the ambient air and is protected in this way from contamination from the ambient air.

After gripping the syringe 6 by the grippers 18, 20, the robot arm is moved in the direction of the arrow D in FIG Fig. 3 moved away from the tool 2. At the same time, if necessary, the tools own ejector support this movement, so that the forces acting selectively on the syringe remain low. This then allows removal from the mold at relatively high temperatures. In individual cases, but can be dispensed by the gripper 18, 20 and the tool ejector. In this case, the syringe 6, which is held in the bell 14 by the grippers 18, 20 is withdrawn from a core of the tool half 2. In this movement, the air flow in the bell 14 is maintained as indicated by the arrows in FIG Fig. 3 is shown. That is, the syringe 6 inside the bell is completely surrounded by high-purity, ionized air and thus shielded from the ambient air. That by pulling off the syringe The resulting volume is filled with purified and conditioned air so that, above all, the interior of the syringes remains clean and any possible charging is already neutralized during its formation. At the same time protects the bell 14 with rapid movement of the robot arm 10 before that the air flow is blown and the protective layer formed by the air flow around the syringe 6 would be destroyed. In this way, the syringe 6 can be reliably protected against contamination during movement and removal from the tool 2, 4.

Following the movement in the direction of the arrow D, the robot arm 10 moves in the direction of the arrow E in FIG Fig. 3 from, whereby the syringe 6 is removed from the space between the tool halves 2 and 4. Subsequently, the syringe 6 can be transported by the robot arm 10 in a further processing, where the syringe can be, for example, siliconized, inspected, assembled, filled, packaged, etc. Also in this further processing, the syringe remains in the robot arm and / or the syringe 6 is preferably flushed via corresponding nozzles with high purity air to protect the syringe from contamination.

The foregoing description refers only to a preferred embodiment of the invention. The invention can be carried out in many variants. For example, the bell 14 on the robot arm 10 can be dispensed with. The grippers 18 and 20 and the actuators 12 and 14 are arranged directly on the robot arm 10. On the robot arm 10 are corresponding air nozzles, which are arranged so that a held by the grippers 18 and 20 component, such as a syringe, even without bell 14 can be completely immersed in gas to protect it from contamination.

Based on FIGS. 4 and 5 is a first arrangement for flow around a high-purity object, in the example shown, a syringe 6, shown. Although the example refers to handling a syringe 6, other high purity components may be handled in the same manner. In Fig. 4 is a top view and in Fig. 5 to see a perspective view of the arrangement. The arrangement consists of two nozzle tubes 30, each having a plurality of nozzles 32. The nozzle tubes 30 extend in the example shown parallel to each other and parallel to the longitudinal axis of the syringe 6. Over the entire length of the nozzle tubes each have a series of nozzles 32 is arranged, through which a fluid or gas is emitted to flow around the syringe 6 and so shield from the environment. At one end, the nozzle tubes 30 are connected to a piping system 34, through which the fluid, in particular a gas, for example, high-purity air is introduced into the nozzle tubes 30. The fluid flow is in FIGS. 4 and 5 indicated by arrows. In this case, the nozzles 32 are aligned so that the flow from two sides are directed substantially at an angle of 90 ° to each other on the syringe 6, so that the syringe 6 can be completely surrounded by the fluid from all sides, and the syringe. 6 encased by the fluid and shielded from the ambient air.

FIGS. 6 and 7 show a variant of the arrangement according to FIGS. 4 and 5 , in which Fig. 6 a top view and Fig. 7 a perspective view of the arrangement shows. In contrast to the arrangement according to FIGS. 4 and 5 are in the arrangement according to FIGS. 6 and 7 three nozzle tubes are provided, which are arranged distributed uniformly around the circumference of the syringe 6 to be protected, so that the syringe 6 is flowed around from all sides with fluid, as in FIGS. 6 and 7 indicated by the arrows. Incidentally, the configuration of the nozzle tubes 30 corresponds to the basis of FIGS. 4 and 5 described embodiment. The three nozzle tubes 30 are provided with a piping system 34 for supply connected to a fluid or gas, wherein the fluid flow in the piping system 34 in FIGS. 6 and 7 is shown by arrows.

FIGS. 8 and 9 show a further arrangement for flowing around a high purity object, in the example of a syringe 6, with a fluid, such as a gas such as high purity air. In the embodiment according to FIGS. 8 and 9 the syringe 6 is surrounded by a bell 14. Fig. 8 shows a plan view and a sectional view of this arrangement, while Fig. 9 a partially cutaway perspective view shows. The bell 14 is cylindrical and provided on one side with an opening 16 through which the syringe 6 can be inserted into the bell 14 and the bell 14 can be slipped over the syringe 6. At the opposite end, the bell 14 is closed and has a gas inlet opening or a nozzle 26, which communicates with a pipe 28 for the supply of a fluid or gas. The fluid flows through the nozzle 26 into the bell 14 as indicated by the arrows in FIG FIGS. 8 and 9 is indicated. In this case, the fluid flows over the outer sides of the syringe 6, so that the syringe 6 is completely surrounded by the fluid, so that the fluid forms a protective jacket around the syringe 6. Subsequently, the fluid exits the bell 14 through the opening 16. The bell 14 has the purpose in this arrangement to prevent a movement of the syringe 6, a fl ow of the surrounding fluid. In this way it can be ensured that the protective sheath is maintained from the fluid flowing around even with rapid movements.

Based on FIGS. 10 and 11 is shown as an object, in the example shown, a syringe 6, from a bell 14 according to FIGS. 8 and 9 in an arrangement according to FIGS. 4 to 7 can be transferred. In addition shows Fig. 10 a partially sectioned side view and Fig. 11 a partially cutaway perspective view. First, the bell 14 with the syringe 6 disposed therein (see characters 8 and 9 ) is brought into a position between the nozzle tubes 30. FIGS. 10 and 1 show an arrangement with two nozzle tubes 30. However, it may also be an arrangement of fewer or more nozzle tubes, for example, three nozzle tubes, as based on FIGS. 6 and 7 explained, be provided. Subsequently, the bell 14 is raised with the syringe 6 remaining between the nozzle tubes 30. From the nozzle tubes 30, the protective fluid flows out through their nozzles 32, as does the nozzle 26 in the bell 14, so that the syringe 6 is also completely surrounded by a fluid when the bell 14 is raised. When the bell 14 is removed, the syringe 6 is freely accessible for further processing steps, such as marking or inspection or assembly, as well as any work on the exterior surfaces. In this case, however, continues to be maintained by the fluid flowing out of the nozzles 32 of the nozzle tubes a protective fluid jacket around the syringe 6 around, so that contamination of the syringe 6 can be prevented by the ambient air. Also in Figures 10 and 1 the fluid flow is indicated by arrows.

FIGS. 12 and 13 show an arrangement similar to the FIGS. 4 to 7 but only one nozzle tube 30 is provided. The nozzle tube 30 extends substantially parallel to the longitudinal axis of the syringe 6, so that the nozzles 32 face the syringe 6. The outflowing fluid flows around, as in Fig. 12 is shown in plan view, the syringe 6 such that the flow at the back of the syringe 6, ie on the side facing away from the nozzle tube 30 of the syringe 6, is brought together again, so that a closed fluid jacket is formed, which the syringe 6 of enclosing all sides protectively. Such an arrangement is primarily suitable for an article such as a round cross-section syringe 6, which allows confluence of the flow at the back of the syringe 6. Depending on the shape and size of the object to be protected have different Types and numbers of nozzles 32 or nozzle tubes 30 are arranged on the circumference of the article to produce a fluid jacket completely surrounding the object.

Fig. 14 shows a schematic overall view of a plant for the production and processing of a high-purity object. The example shown relates to a system for producing a medical container such as a syringe 6. The system consists essentially of an injection molding machine 36 and a processing plant 38. The injection molding machine 36 has two tool halves 2 and 4, from which the syringe 6, as shown in FIGS FIGS. 1 to 3 is removed by a robot arm 10 with a gripping device 12 and a bell 14 is removed. In this case, the syringe 6 is constantly flowed around by a gas to protect the sprite 6 of Vorverunreinigungen from the ambient air. Subsequently, the syringe 6 is transferred in the bell 14 with constant flow around the gas from the robot arm 10 in the further processing device 38, as indicated by the arrow 1 in FIG Fig. 14 is indicated. The processing plant 38 may be a closed system in which defined environmental conditions prevail. In the further processing system 38, the syringe 6 from the bell 14 in an arrangement according to FIG FIGS. 4 to 7 or FIGS. 12 and 13 transferred, as based on FIGS. 8 and 9 has been explained in detail. The arrangement of the nozzle tubes and a, not explained in detail here holder for the syringe 6 are arranged on a carousel 40, which further promotes the syringe 6 together with the nozzle tubes 30 by rotation in the direction of arrow 4 to the stations II, III and IV. The number of stations required depends on the processing steps during further processing. At stations II, III and IV, other arrangements of nozzle tubes 30 are shown. This is intended to indicate that, depending on the intended use and the type of article, different arrangements of nozzle tubes 30, for example according to FIGS FIGS. 4 to 7 and 12 and 13 on the carousel 40 can be arranged. The further processing steps for the syringe 6 may be, for example, a siliconization, a control, an assembly with further syringes or container parts and / or a filling of the syringe 6. For this purpose, the syringe 6 is further promoted by rotation of the carousel 40 from station to station, where a processing step is carried out in each case. In this case, the nozzle tubes 30 rotate with the syringe 6 with the carousel 40, so that the syringe 6 can be constantly flowing around a protective fluid. In this way, during the entire further processing, a protective fluid jacket can be maintained, which protects the syringe 6 from contamination from the environment.

Fig. 15 shows an alternative arrangement Fig. 14 , The system according to Fig. 15 is similar to that according to Fig. 14 , The injection molding machine 36 corresponds to the basis of Fig. 14 described injection molding machine. In contrast to the arrangement according to Fig. 14 is on the robot arm 10 no bell 14 is arranged. Instead, two nozzle tubes 30 with nozzles 32 are arranged on the robot arm, through which the fluid is passed around the syringe 6 to form a protective jacket. Incidentally, the embodiment of the gripping device 12, as they are based on FIGS. 1 to 3 was explained. The syringe 6 is removed as described above from the injection molding machine 36 and transferred to the processing plant 38. In contrast to the arrangement according to Fig. 14 with this arrangement in the processing plant 38 no carousel 40, but a linear stage 42 is arranged, through which the syringe 6 is transferred together with the surrounding nozzle tubes from station I to station II, station III, etc., depending on how many processing stations provided are. At the processing stations different processing steps, such as siliconization, inspection, assembly, etc. are made. In this case, the syringe 6 between the stations is always arranged together with the surrounding and on the linear stage 42 Nozzle tubes 30 moves, so that the protective fluid jacket is maintained steadily.

At the station 1, the syringe 6 is first deposited by the robot arm 10 between the nozzle tubes 30 on the linear stage 42. This transfer is similar to that based on the FIGS. 8 and 9 explained transfer, with the difference that instead of a bell 14 on the robot arm 10 also nozzle tubes 30 are arranged. The nozzle tubes 30 on the robot arm 10 engage between the nozzle tubes 30 on the linear table 32, so that the syringe 6 can constantly be flowed around by fluid. Instead of the nozzle tubes 30 on the robot arm 10, a bell 14 can also be provided in this arrangement, as indicated at station II as an alternative embodiment. In this case, the transfer between the nozzle tubes 30, as based on FIGS. 8 and 9 explained. Further, different numbers of nozzle tubes 30 can be placed at the respective receiving positions for a syringe 6, as shown by the different arrangements at Station I, Station II and Station III. The numbers of the nozzle tubes depend on the geometry of the syringe 6 or an object to be protected and the processing step to be carried out. The arrangement is always chosen so that the article or syringe 6 can be adequately protected from contamination by the surrounding fluid. In the example shown in Figures 14 and 15 At the individual stations, different arrangements of nozzle tubes 30 for illustrating various embodiments are shown. In fact, however, the syringe 6 is conveyed in the same arrangement of nozzle tubes 30 through the carousel 40 and the linear stage 42 from station to station as indicated by the arrow 4 and the arrow 7.

Figures 16 and 17 show in flow charts once again the sequence of the method described above. It is in the flow charts not only the manufacture of the article or the syringe 6 but also the manufacture and assembly of all accessories and the packaging described. The process steps 1 to 7 in Fig. 16 refer directly to the production of the syringe or the container 6. In step 1, the container or the syringe is produced by injection molding. In this case, due to the high temperatures prevailing during casting, a germ-free, high-free object is produced. When removing from the tool, the article or the container preferably has a temperature between 5 ° C and 150 ° C (PP / PE, for example 15 ° C to 100 ° C, PC, for example 70 ° C to 140 depending on the type of plastic used ° C, PET for example 5 ° C to 60 ° C, PVC for example 20 ° C to 85 ° C and COP for example 50 ° C to 150 ° C). In method step 2, a siliconization of the sprayed container takes place. In method step 3, an inspection or control follows. In process step 4, a closure is then mounted on the container, which has been manufactured in the process steps 8 and 9, as will be described later. In method step 5, a subsequent inspection or control then follows, before then in method step 6 a primary and secondary packaging takes place with a subsequent re-inspection. The transport packaging is produced in accordance with method steps 10 and 11 described later and supplied in method step 6. As process step 7 then follows the shipping of the finished and packaged product. The process steps 1 and 6, which in Fig. 16 are enclosed by a dotted line, all take place under the above-described shielding of the article or container 6 by flowing high-purity air. It is a local air flow, which flows directly around the container to be processed and handled. The air is preferably supplied at a pressure between 300 and 3500 hPa. The air is filtered before being fed to the object to be flowed around. The filter used for this purpose preferably has one Pore size between 0.1 and 3 microns and a deposition rate well over 99%.

The closure mounted on the container 6 in method step 4 is either likewise produced by injection molding in method 8 or introduced into the process as a purchased part. The closure is delivered in a highly pure form or, as described above using the example of the container, removed in a highly pure form directly from the injection molding machine. In method step 9, an inspection or testing of the part follows before the closure is mounted on the container in step 4. The transport packaging in which the container is packed in method step 6 is fed to the process in method step 10. The packaging is either delivered as a purchased part in a highly purified, ie germ-free or germ-free form or directly, as described above with reference to the container, taken from an injection molding machine. The method steps 10 and 11 as well as 8 and 9 are each carried out in such a way that the corresponding object is shielded by high-purity air, which flows around the object directly, from the ambient air to protect it from contamination. This is in Fig. 16 indicated by the dotted lines, ie the process steps shown in the dotted lines are performed using the shielding of the invention, as described in detail above.

Fig. 17 shows a further flow chart, in which the production of a closure and / or other component is shown, which after filling the container, which according to the sequence in Fig. 16 was manufactured, to be mounted. This closure is used for example after filling in the container or the syringe 6 and later used when using the syringe as a piston. In steps 13, 19 and 21, corresponding parts of the closure are introduced into the process. This can either be in the form of purchased parts happen, which are delivered in a highly pure form and introduced into the process. Alternatively, the parts, as described above using the example of the container, hot-formed and removed while the machine is still warm. In this state, the articles are highly pure due to the high processing temperatures, so that they can be further processed directly. Steps 14, 20 and 22 are followed by an inspection or control of the individual parts produced or supplied in this way. The handling of the individual parts is carried out under shielding by the objects directly around high-purity air, as described above using the example of the container or the syringe 6. An assembly of the individual parts takes place in method step 15, wherein in this method step the components supplied in method steps 13, 19 and 21 are brought together. In addition to the assembly, it is also possible to siliconise the components, in particular the closure serving as a piston. Subsequently, another inspection follows in step 16 before the article or closure thus mounted is then packed in step 17 and inspected again. In step 18 then the shipping of this part, which is preferred together with the shipping of the container according to method step 7 in Fig. 16 he follows. Also in Fig. 17 are the process steps in which the handling of a high-purity object according to the method described above using the example of the container or the syringe 6, bounded by dotted lines.

LIST OF REFERENCE NUMBERS

2, 4 -

tool halves

6 -

syringe

8th -

jet

10 -

robot arm

12 -

gripper

14 -

Bell jar

16 -

opening

18, 20 -

grab

22,24 -

actuators

26 -

Gas inlet opening, nozzle

28 -

management

30

nozzle tubes

32

jet

34

Piping

36

injection molding machine

38

Processing plant

40

carousel

42

linear Stage

Claims (27)

1. A method for handling a highly pure object (6) hot-moulded in a tool, with which the initially highly pure object (6) during the complete removal procedure from the tool and at least the subsequent handling procedure, is shielded from the surroundings by way of a fluid flowing around it, wherein with the handling of the object, at least one nozzle for the discharge of the fluid is led along with the object.
2. A method according to claim 1, with which the object is a part of a medical receptacle (6) or is a medical receptacle (6).
3. A method according to claim 1, with which the fluid which flows around the object (6) is a gas, in particular air or filtered air.
4. A method according to one of the preceding claims, with which the fluid which flows around the object (6), is conditioned air.
5. A method according to one of the preceding claims, with which the fluid which flows around the object (6), is ionised air.
6. A method according to one of the preceding claims, with which the fluid which flows around the object (6), at least as a share, contains a germicidal fluid or gas.
7. A method according to one of the claims 1 to 6, with which the circumflow of the object (6) with the fluid begins when the object (6) is still located in the tool (2, 4).
8. A method according to one of the claims 1 to 7, with which the removal of the object (6) from the tool (2, 4) is effected by machine in a defined manner.
9. A method according to claim 8, with which the object (6) is removed from the tool (2, 4) by way of a robot (10) and simultaneously is separated from the tool (2, 4) by way of an ejector arranged in the tool (2, 4).
10. A method according to claim 8 or 9, with which the removal of the object (6) from the tool (2, 4) is effected with a low initial speed.
11. A method according to one of the claims 1 to 10, with which the removal of the object (6) from the tool (2, 4) is effected before the complete cooling.
12. A method according to one of the claims 1 to 11, with which the removal of the object from the tool (2, 4) is effected by a robot (10), and at least one nozzle (8) is arranged on the robot (10), by way of which the object (6) is circumflowed by the fluid.
13. A method according to one of the claims 1 to 12, with which nozzles (8) for circumflowing the object (6) with the fluid are arranged in at least one part (2) of the tool.
14. A method according to one of the claims 1 to 13, with which the tool (2, 4) has a surface which is treated in a manner such that it has a minimal adhesion capability.
15. A method according to one of the claims 1 to 14, with which the object (6), additionally to the circumflow by the fluid directly on removal from the tool (2, 4), is surrounded by a protective bell (14).
16. A method according to one of the claims 1 to 15, with which an automatic or semi-automatic further processing follows the removal of the object (6) from the tool (2, 4).
17. A method according to one of the claims 1 to 16, with which the circumflow, by the fluid, of the object (6) removed from the tool (2, 4), is used for the rapid cooling of the object (6).
18. A method according to one of the claims 1 to 17, with which the circumflow, by the fluid, of the object (6) removed from the tool (2, 4), is used for slow cooling.
19. A method according to one of the preceding claims, with which the object (6) is joined together or assembled with further components.
20. A method according to one of the preceding claims, with which the object (6) is a receptacle which is assembled with further components and/or filled and closed.
21. A method according to one of the preceding claims, with which at least individual method steps take place in a controlled surrounding of Class 1000 or lesser purity.
22. A method according to claims 1 to 21, with which a siliconisation of the object (6) is effected directly after removal of the object (6) from the tool (2, 4).
23. A method according to one of the preceding claims, with which the circumflowing fluid is used for influencing the surface characteristics of the object (6).
24. A method according to claim 23, with which the circumflowing fluid is used for curing and/or drying a surface coating.
25. A device for removal from the tool and handling a highly pure object (6) which is hot-moulded in a tool, by way of a handling device (10), characterised in that at least one nozzle (26) for the discharge of a fluid is arranged on the handling device (10), in a manner such that an object (6) located in the handling means (10) is circumflowed by the fluid.
26. A device according to claim 25, with which the handling device is a robot arm (10) with a gripper means (12), wherein the at least one nozzle (26) is arranged in the vicinity of the gripper means (12).
27. A device according to claim 25 or 26, with which furthermore a protective shield (14) at least partly covering the fluid flowing out is arranged on the handling device (10).

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